Common deficiencies in generic drug review cluster around a small set of principles: starting material justification, excipient limits, impurity qualification, stability design, sterility assurance, and analytical method validity. Reviewers flag the same issues across guidance documents because each bears directly on product quality, safety, and efficacy. Sponsors who settle these areas before submission cut review cycles sharply. Why application quality changes review speed A generic application is judged on more than whether the product works. Reviewers must be able to trace every quality decision back to a defensible rationale, and a dossier that leaves that chain implicit invites questions. Approval times show it. In the United States, a series of user-fee laws passed in 2012, 2017, and 2022 came with guidance documents aimed squarely at dossier completeness and format. Median approval time for generic drugs fell from 31 months in 2012 to 23 months in 2021, while the first-cycle ap...